ARROW - FlexTip Plus(R) Epidural Catheterization Kit - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: FlexTip Plus(R) Epidural Catheterization Kit

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More Product Details

Catalog Number

ASK-05500-UMC

Brand Name

ARROW

Version/Model Number

IPN045683

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140110,K140110

Product Code Details

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Device Record Status

Public Device Record Key

d514b4f2-53ff-4cd3-8a0c-047b8c81ceda

Public Version Date

June 21, 2022

Public Version Number

10

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

30801902049590

Quantity per Package

10

Contains DI Package

00801902049599

Package Discontinue Date

June 15, 2022

Package Status

Not in Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26